Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
NCT ID: NCT04839705
Last Updated: 2025-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2022-08-24
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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WEB Aneurysm Embolization Device
WEB Aneurysm Embolization Device The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.
WEB
Device: WEB The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.
Other Names:
• WEB Aneurysm Embolization Device
Interventions
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WEB
Device: WEB The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.
Other Names:
• WEB Aneurysm Embolization Device
Eligibility Criteria
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Inclusion Criteria
* Patient must have a single ruptured or unruptured IA requiring treatment
* Patient must sign and date an IRN approved written informed consent prior to initiation of any study procedures
Exclusion Criteria
* Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days
* Patient has had an SAH from a non-index IA or other intracranial hemorrhage within 90 days
* Patient index IA was previously treated
* Patient is pregnant
18 Years
ALL
No
Sponsors
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Microvention-Terumo, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Adam Arthur, MD
Role: PRINCIPAL_INVESTIGATOR
Methodist University Hospital, Memphis TN
David Fiorella, MD
Role: PRINCIPAL_INVESTIGATOR
Stony Brook University, Stony Brook NY
Locations
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Memorial Health Systems
Hollywood, Florida, United States
Orlando Health Neuroscience Institute
Orlando, Florida, United States
The Queen's Medical Center Neuroscience Institute
Honolulu, Hawaii, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Health System
Kansas City, Kansas, United States
Baptist Health Systems
Lexington, Kentucky, United States
University of Kentucky, Department of Neurosurgery
Lexington, Kentucky, United States
Norton Healthcare
Louisville, Kentucky, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, United States
University of Maryland, Baltimore
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Brigham Incorporated
Boston, Massachusetts, United States
UMass Memorial Health
Worcester, Massachusetts, United States
Abbott Northwestern Hospital Allina Health
Minneapolis, Minnesota, United States
The Washington University
St Louis, Missouri, United States
Albany Medical Center
Albany, New York, United States
University of Buffalo
Buffalo, New York, United States
Northshore University Hospital/Northwell Health
Manhasset, New York, United States
SUNY Stony Brook
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University
Durham, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
OhioHealth Research Institute
Columbus, Ohio, United States
The Toledo Hospital d/b/a ProMedica Toledo Hospital
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Semmes Murphey
Memphis, Tennessee, United States
West Virginia University
Morgantown, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CL11010-001
Identifier Type: -
Identifier Source: org_study_id
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